evidence table 1: diabetes - home - centers for medicare ... · evidence table 1: diabetes first...

N/A = Not Available or Not ApplicableNOS = Not Otherwise Specified* Unless otherwise specified, Mean (Standard Deviation) reported.

156

Evidence Table 1: Diabetes

First AuthorYear(ID)

Condition (Type)Study DesignQualityPopulationCharacteristics Arm

InterventionSample Size

InterventionCharacteristics

Meta-Analysis Data* or OutcomesFollow-up Time(s)

1 Dietary monitoring (Office visit)Education (Office visit)Education (One-on-one)Education (Reading material)Exercise diary (Office visit)Feedback (Office visit)Practice methods (Protocols)

n Entered: n/an Analyzed: 27

Tailored: YesGroup Setting: NoFeedback: YesPsychological: NoPrimary MD: n/a

Allen BT, 1990(#2201)

Diabetes (Type II)

RCT

Jadad Score: 3

Diagnostic criteria:FBS

Comorbidities:Obesity andcholesterol 2 Dietary monitoring (Office visit)

Education (Office visit)Education (One-on-one)Education (Reading material)Exercise diary (Office visit)Feedback (Office visit)Practice methods (Protocols)



Excluded from meta-analysis as no usual careor comparable control group.

Patients who self monitored diabetes usingurine testing (arm 1) had similar statisticallysignificant reductions in fasting blood glucose,glycosylated hemoglobin, and weight as didpatients utilizing serum glucose testing (arm 2).No appreciable differences between groupswere noted.

Follow-up times: 1 MO, 2 MO, 3 MO, 4 MO, 5MO, 6 MO

1 Usual Care (n/a)


Tailored: n/aGroup Setting: n/aFeedback: n/aPsychological: n/aPrimary MD: n/a

Anderson R M, 1995(#747)

Diabetes (n/a)

CCT

Jadad Score: 0

Diagnostic criteria:n/a

Comorbidities:n/a

2 Education (Group meeting)Education (Video/audio tapes)Feedback (Group meeting)


Tailored: YesGroup Setting: YesFeedback: YesPsychological: NoPrimary MD: n/a

Excluded from meta-analysis as notrandomized.

Patients receiving a patient empowermenteducation program (arm 2) had reductions inglycosylated hemoglobin that were greater thancontrols and were statistically significant(p=0.05). Intervention subjects also improved inall self-efficacy sub-scales, which weresustained at 12-week follow-up.

Follow-up times: 6 WK, 12 WK

Evidence Table 1: Diabetes (con't)


157






1 Control (n/a)Reminders (Mail)

n Entered: 135n Analyzed: 111


Anon, DICET, 1994(#2614)

Diabetes(Types I and II)

RCT

Jadad Score: 2


Comorbidities:Hypertension,neuropathy, andcholesterol

2 Practice methods (Reading material)Reminders (Computer program)Reminders (Mail)




Patients randomized to intervention (arm 2) hada greater number of MD evaluations but nodifference in diabetes related hospitalizationscompared with controls (arm 1). BMI trendswere higher in intervention patients comparedwith controls, but there were no treatmentdifferences in glycosylated hemoglobin, systolicor diastolic blood pressure. There were also nosignificant differences in diabetes knowledge,anxiety, depression, satisfaction with treatmentor self reported well-being.

Follow-up times: 2 YR1 Education (Group meeting)

Education (Instructional manuals)

n Entered: 20n Analyzed: n/a

Tailored: NoGroup Setting: YesFeedback: NoPsychological: NoPrimary MD: n/a

Arseneau D L, 1994(#749)

Diabetes (Type II)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Education (Group meeting)Education (Office visit)




Though knowledge and% ideal body weightsignificantly improved for Learning ActivityPackages (arm 1) at 5 months and HgbA1c andbehavior improved for diabetes class arm, onlyknowledge scores were significantly higher at 5months for the LAP arm.

Follow-up times: 2 MO, 5 MO



158






1 Control (n/a)Advocacy training (One-on-one)Counseling/therapy (One-on-one)Education (Group meeting)Follow up (One-on-one)



Aubert RE, 1998(#2581)


RCT

Jadad Score: 1

Diagnostic criteria:MD

Comorbidities:Obesity, DM,tobacco abuse, andcholesterol

2 Advocacy training (One-on-one)Consultation w/specialists (Protocols)Counseling/therapy (One-on-one)Counseling/therapy (Telephone)Education (Group meeting)Education (One-on-one)Follow up (One-on-one)


Tailored: YesGroup Setting: YesFeedback: YesPsychological: YesPrimary MD: n/a


Intervention subjects (arm 2) had greaterdecreases in HbA1c levels than those receivingusual care (arm 1) (1.7% versus 0.6% p<0.01).Fasting serum glucose was lower in interventionsubjects by a mean of 48 mg/dl versus 15 mg/dl(p=0.003). Self-rated health also improved inthe intervention group (p=0.02).


1 Control (n/a)Education (One-on-one)Education (Reading material)



Bethea DC, 1989(#2105)


CCT

Jadad Score: 0


Comorbidities:n/a

2 Education (One-on-one)Education (Reading material)Education (Video/audio tapes)


Tailored: YesGroup Setting: NoFeedback: NoPsychological: NoPrimary MD: n/a


Use of videotape instruction (arm 2) resulted insimilar diabetes knowledge levels comparedwith conventional instruction in hospitalizedpatients (arm 1).

Follow-up times: 45 MI



159






1 Usual Care (n/a)



Bloomgarden ZT,1987(#2172)


RCT

Jadad Score: 2


Comorbidities:Heart disease,hypertension, kidneydisease, tobaccoabuse, cholesteroland retinopathy

2 Education (Group meeting)Education (Other mechanisms)Education (Video/audio tapes)


Tailored: YesGroup Setting: YesFeedback: NoPsychological: NoPrimary MD: No

Follow-up time not in 3 - 12 months.

Though subjects randomized to an educationintervention (arm 2) demonstrated increasedknowledge compared with usual care group(arm 1) (p=0.007) and had significant reductionsin HbA1c and fasting blood glucose, thesereductions in biochemical markers were notsignificantly greater than in the usual caregroup. There were also no changes incholesterol, blood pressure, or foot lesions andhealth service utilization was unaffected.

Follow-up times: 18 MO



160






1 Usual Care (n/a)



2 Cognitive-behavioral (Office visit)Contracts (Office visit)Material incentive (Other mechanisms)


Tailored: YesGroup Setting: NoFeedback: YesPsychological: YesPrimary MD: No

3 Cognitive-behavioral (Office visit)Contracts (Office visit)Feedback (Office visit)Material incentive (Other mechanisms)



Boehm S, 1993(#754)

Diabetes (Type II)

RCT

Jadad Score: 1


Comorbidities:n/a

4 Cognitive-behavioral (Office visit)Contracts (Office visit)Education (Group meeting)Education (Instructional manuals)Feedback (Office visit)Material incentive (Other mechanisms)


Tailored: YesGroup Setting: YesFeedback: YesPsychological: YesPrimary MD: No

Insufficient statistics for meta-analysis.

Behavioral strategy interventions (arms 2, 3 and4) resulted in no differences in glycosylatedhemoglobin and weight loss betweenintervention and control groups.

Follow-up times: n/a



161






1 Control (n/a)Education (One-on-one)



2 Education (Group meeting)Education (One-on-one)



3 Education (Group meeting)Education (One-on-one)



Campbell EM, 1996(#2586)

Diabetes (Type II)

RCT

Jadad Score: 1


Comorbidities:Hypertension andtobacco abuse

4 Cognitive-behavioral (Home visit)Cognitive-behavioral (One-on-one)Cognitive-behavioral (Telephone)Contracts (One-on-one)Education (One-on-one)Feedback (One-on-one)Social support (n/a)




Control (arm 1) were more likely to have anincrease in intensity of diabetes treatment at 6-month follow-up (p=0.04) than interventionsubjects (arms 2, 3, and 4). Behavior program(arm 4) and group education (arm 2) patientshad greater improvement in knowledge scoresat 6-month follow-up, but differences were notsustained at 12 months. Greater reductions indiastolic blood pressure were seen for thoseattending behavioral interventions (p=0.02). Nodifference in change between groups occurredfor HbA1c, BMI, total cholesterol, or systolicblood pressure.

Follow-up times: 3 MO, 6 MO, 12 MO



162






1 Control (n/a)Education (n/a)



2 Education (Group meeting)Education (One-on-one)Education (n/a)Goal setting (Group meeting)


Tailored: YesGroup Setting: YesFeedback: YesPsychological: NoPrimary MD: No

D'Eramo-Melkus GA,1992(#2202)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:HgbA1C and GTT

Comorbidities:Obesity

3 Counseling/therapy (One-on-one)Education (Group meeting)Education (One-on-one)Education (n/a)Goal setting (Group meeting)



Fasting blood glucose (mM) at 6 months:Arm 1 = 12.2 (5.5)Arm 2 = 9.5 (3.6)Arm 3 = 9.0 (3.0)

HbA1 (%) at 6 months:Arm 1 = 10.5 (3.2)Arm 2 = 9.2 (3.3)Arm 3 = 8.3 (2.7)

Weight (lbs) at 6 months:Arm 1 = 205.1 (25.6)Arm 2 = 200.7 (30.4)Arm 3 = 191.8 (31.7)


1 Control (n/a)Counseling/therapy (Home visit)Counseling/therapy (n/a)



de Bont AJ, 1981(#2210)

Diabetes (Type II)

RCT

Jadad Score: 2


Comorbidities:Obesity and tobaccoabuse

2 Counseling/therapy (Home visit)Counseling/therapy (n/a)


Tailored: YesGroup Setting: NoFeedback: NoPsychological: YesPrimary MD: n/a


Patients in both intervention group (arm 2) andcontrol group (arm 1) lost weight. Thoughcholesterol levels fell significantly in the low fatgroup (arm 2) (p<0.001), mean plasma glucoseand HbA1c remained unchanged.




163






1 Usual Care (n/a)



Emori KH, 1964(#2118)

Diabetes (Type II)

RCT

Jadad Score: 2



2 Education (One-on-one)Education (Reading material)Education (Video/audio tapes)


Tailored: YesGroup Setting: NoFeedback: NoPsychological: NoPrimary MD: No


Intervention subjects (arm 2) had greaterknowledge (p<0.005) and lower glycosylatedlevels (10.4% versus 11.8%, p<0.05) than usualcare group (arm 1) did at 4-6 weeks after theprogram concluded. Change in body weight wasnot different between groups.

Follow-up times: 5 DY, 4 WK

1 Control (n/a)Education (Group meeting)



Falkenberg MG, 1986(#2190)

Diabetes (Type II)

RCT

Jadad Score: 2



2 Education (Group meeting)Education (Instructional manuals)



HbA1 (%) at 6 months:Arm 1 = 8.1 (1.0)Arm 2 = 7.2 (0.9)




164






1 Usual Care (n/a)



Frost G, 1994(#791)

Diabetes (Type II)

RCT

Jadad Score: 3


Comorbidities:n/a

2 Counseling/therapy (Instructionalmanuals)Counseling/therapy (Reading material)Dietary monitoring (Instructional manuals)Dietary monitoring (Office visit)


Tailored: YesGroup Setting: NoFeedback: NoPsychological: YesPrimary MD: No

Fasting blood glucose (mmol/L) at 12 weeks:Arm 1 = 9.8 (3.1)Arm 2 = 9.6 (3.0)

Weight (kg) at 12 weeks:Arm 1 = 82.9 (14.8)Arm 2 = 84.8 (23.5)


1 Usual Care (n/a)



2 Education (Group meeting)



Glasgow RE/ToobertDJ, 1989(#2209)

Diabetes (Type II)

RCT

Jadad Score: 1

Diagnostic criteria:HgbA1C and MD

Comorbidities:n/a

3 Dietary monitoring (Group meeting)Education (Group meeting)




Individuals participating in 2 nutrition groups(arms 2 and 3) demonstrated decreased caloricintake compared with usual care group (arm 1).The addition of a social learning program (arm3) had a significant decrease in weight at 2-month follow-up. Intervention conditionsproduced a marginal improvement in fastingblood glucose (p<0.08).




165






1 Usual Care (n/a)



Glasgow RE, 1992(#2212)

Diabetes (Type II)

RCT

Jadad Score: 1

Diagnostic criteria:Welborn

Comorbidities:Heart disease andarthritis

2 Cognitive-behavioral (Group meeting)Education (Group meeting)Exercise program (Group meeting)


Tailored: YesGroup Setting: YesFeedback: NoPsychological: YesPrimary MD: No

Glycosolated hemoglobin (%) at 6 months:Arm 1 = 6.4 (1.4)Arm 2 = 6.7 (1.7)

Weight (lbs) at 6 months:Arm 1 = 181.0 (34.7)Arm 2 = 186.1 (32.6)

Follow-up times: 10 WK

1 Usual Care (n/a)

n Entered: n/an Analyzed: n/a


Glasgow R E, 1996(#799)


RCT

Jadad Score: 2


Comorbidities:n/a

2 Clinical reviews w/patient (Telephone)Consultation w/specialists (Office visit)Education (Reading material)Education (Video/audio tapes)Feedback (Computer program)Reminders (Telephone)


Tailored: YesGroup Setting: NoFeedback: YesPsychological: NoPrimary MD: Yes


Patients who received a brief intervention (arm2) had no improvement in HbA1C at 3-monthfollow-up when compared with usual care group(arm 1). However serum cholesterol wassignificantly lower (p<0.001) in the interventiongroup as were 4 dietary behavioral measures.Though patient satisfaction was improved,quality of life was not.




166






1 Control (n/a)Clinical reviews w/patient (One-on-one)Education (Office visit)Education (Reading material)



Greenfield S, 1988(#803)

Diabetes (n/a)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Advocacy training (Office visit)Clinical reviews w/patient (Office visit)Education (Reading material)



HbA (%) at 12 weeks:Arm 1 = 10.6 (2.2)Arm 2 = 9.1 (1.9)




167






1 Control (n/a)Counseling/therapy (Office visit)Reminders (Office visit)



2 Clinical reviews w/patient (One-on-one)Counseling/therapy (Office visit)Education (Group meeting)Education (Reading material)Placebo medication (n/a)Reminders (Office visit)



Hanefield M, 1991(#2595)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:FBS and GTT

Comorbidities:Hypertension,obesity, tobaccoabuse, andhyperlipoproteinemia

3 Cholesterol lowering medication (n/a)Clinical reviews w/patient (One-on-one)Counseling/therapy (Office visit)Education (Group meeting)Education (Reading material)Reminders (Office visit)




Intervention subjects (arms 2 and 3) reportedgreater physical activity than controls (arm 1) at5-year follow-up (p<0.01). Intervention subjectsalso had better control of glucose and lowersystolic blood pressure (143 versus 154 mmHg,p<0.01) and required fewer antidiabetic drugs.Though no differences between groups werenoted for myocardial infarction incidence,cumulative incidence mortality rates suggesteda benefit from intervention.

Follow-up times: 2 YR, 5 YR



168






1 Control (n/a)Education (One-on-one)



Hassell J, 1975(#2121)

Diabetes (n/a)

RCT

Jadad Score: 2


Comorbidities:n/a



Tailored: NoGroup Setting: YesFeedback: NoPsychological: NoPrimary MD: No

Excluded from meta-analysis as no relevantoutcomes.

Classroom teaching methods (arm 2) resulted ingreater diabetes knowledge compared withtraditional bedside teaching methods (arm 1)(77% post-test scores compared with 56%).





2 Education (n/a)Practice methods (Protocols)Reminders (n/a)(Care provided by specialists andgeneralists)



Hoskins PL, 1993(#2597)


RCT

Jadad Score: 1


Comorbidities:Hypertension andobesity

3 Education (n/a)Practice methods (Protocols)(Care provided by generalists alone)




Subjects who participated in a system of careshared between specialist and generalist (arm2) had significantly greater visit compliance thanthose with generalists alone (arm 3) (72%versus 35%, p<0.04). HbA1c improvedsignificantly in all 3 groups but no differencesbetween groups were noted. Nor were thereblood pressure differences between groups andweight decreased marginally in all 3 groupsthough this was statistically significant only inthe shared care group (arm 2) (p<0.04).

Follow-up times: 1 YR



169






1 Usual Care (n/a)



Jaber LA, 1996(#2598)

Diabetes (Type II)

RCT

Jadad Score: 2


Comorbidities:Hypertension,obesity, andhyperlipedemia

2 Consultation w/specialists (One-on-one)Counseling/therapy (One-on-one)Education (One-on-one)Education (Reading material)Feedback (One-on-one)



Fasting blood glucose (mmol/L) at 4 months:Arm 1 = 11.0 (3.9)Arm 2 = 8.5 (2.3)

Glycated hemoglobin (%) at 4 months:Arm 1 = 12.1 (3.7)Arm 2 = 9.2 (2.1)


1 Usual Care (n/a)



Jennings PE, 1987(#2126)

Diabetes (Type I)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Patient directed discussion group (Groupmeeting)



HbA1 level (%) at 12 months:Arm 1 = 10.9 (2.3)Arm 2 = 9.9 (2.3)




170









2 Cognitive-behavioral (Group meeting)Dietary monitoring (Self-delivery)Education (Group meeting)



Kaplan, 1985(#2817)

Diabetes (Type II)

RCT

Jadad Score: 1

Diagnostic criteria:FBS and MD


3 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Exercise diary (Self-delivery)Exercise program (Group meeting)




Those participating in the diet intervention (arm2) lost more weight than the other 3 groups(arms 1, 3, and 4) (p<0.05). HDL cholesterolwas also significantly higher in this group(p<0.01). No differences in glycosylatedhemoglobin between groups were noted.


4 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Dietary monitoring (Self-delivery)Education (Group meeting)Exercise diary (Self-delivery)Exercise program (Group meeting)

n Entered: .n Analyzed: 16




171






1 Control (n/a)Education (Group meeting)Education (n/a)Financial incentives (Group meeting)



2 Cognitive-behavioral (Group meeting)Dietary monitoring (Other mechanisms)Education (n/a)Exercise program (Group meeting)Feedback (Group meeting)Financial incentives (Group meeting)



Kaplan RM, 1987(#2175)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:FBS and MD


3 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Education (Group meeting)Exercise program (Group meeting)Feedback (Group meeting)Financial incentives (Group meeting)




At 18-months follow-up diabetic patientsreceiving behavioral interventions in a combineddiet and exercise program (arms 2, 3, and 4)achieved greater reductions in glycosylatedhemoglobin than those receiving only diet,exercise, or control interventions (arm 1)(p<0.05). Changes between other interventionswere not significant. Improvements in quality oflife measures were also greatest in thecombined group (arm 2) (p<0.05).

Follow-up times: 3 MO, 6 MO, 12 MO, 18 MO



172






4 Cognitive-behavioral (Group meeting)Dietary monitoring (Group meeting)Education (n/a)Exercise program (Group meeting)Financial incentives (Group meeting)



1 Education (Group meeting)Education (Instructional manuals)Education (Video/audio tapes)


Tailored: YesGroup Setting: YesFeedback: NoPsychological: NoPrimary MD: n/a

Kendall PA, 1990(#2207)

Diabetes (Type II)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Education (Group meeting)Education (Reading material)Education (Video/audio tapes)




Both diet guide (arm 1) and exchange liststreatment group (arm 2) demonstratedsignificantly higher levels of self-efficacycompared with their pre-workshop scores(p<0.05). Knowledge scores were alsosignificantly higher in both groups (p<0.01).Applied nutrition knowledge scores werehowever greater for the diet guide group(p<0.01).

Follow-up times: 3 MO, 6 MOKinmonth AL, 1998(#2599)

Diabetes (Type II)

RCT

Jadad Score: 1





The intervention group (arm 2) reported bettercommunication with doctors, greater treatmentsatisfaction and sense of well-being. BMI and



173







Comorbidities:Heart disease,hypertension,obesity, and tobaccoabuse

2 Advocacy training (Reading material)Education (Group meeting)Education (Instructional manuals)Practice methods (Group meeting)


Tailored: YesGroup Setting: YesFeedback: NoPsychological: YesPrimary MD: n/a

triglyceride concentrations were, however, lowerin the intervention group (arm 2) then in thecontrol group (arm 1).


1 Control (n/a)Clinical reviews w/patient (Office visit)Education (One-on-one)Education (Reading material)



Korhonen T, 1983(#2259)

Diabetes (n/a)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Clinical reviews w/patient (Office visit)Education (Group meeting)Education (One-on-one)


Tailored: YesGroup Setting: YesFeedback: YesPsychological: NoPrimary MD: Yes


Follow-up times: 1 MO, 3 MO, 6 MO, 9 MO, 12MO, 15 MO, 18 MO

1 Usual Care (n/a)



Kumana CR/Ma JT,1988(#2130)

Diabetes (n/a)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Education (Reading material)


Tailored: NoGroup Setting: NoFeedback: NoPsychological: NoPrimary MD: No

Excluded from meta-analysis as no relevantoutcome.

Of diabetic patients receiving drug informationsheets (arm 2), those who recalled receipt hadthe greatest improvement in follow-up testscores (4.53 to 6.16, p<0.001) but follow-up testscores were significantly higher (p<0.001) inboth intervention group (arm 2) and usual caregroup (arm 1).




174






1 Control (n/a)Counseling/therapy (Office visit)Education (Office visit)



Laitinen JH/AholaIE/SarkkinenES/Winberg RL, 1993(#2176)

Diabetes (Type II)

RCT

Jadad Score: 1

Diagnostic criteria:FBS and WHO

Comorbidities:Heart disease,hypertension,obesity, CHF, andstroke

2 Goal setting (Group meeting)




Glycated hemoglobin A (%) at 3 months:Arm 1 = 7.8 (2.0)Arm 2 = 7.1 (1.8)

Weight (kg) at 3 months:Arm 1 = 88.8 (14.0)Arm 2 = 88.3 (14.1)




175






1 Usual Care (n/a)



Litzelman D K, 1993(#828)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:FBS, HgbA1C, and

NDDG

Comorbidities:n/a

2 Counseling/therapy (Office visit)Dietary monitoring (Group meeting)Dietary monitoring (Self-delivery)Education (Group meeting)Education (Office visit)Clinical reviews w/patient (Other

mechanisms)Contracts (Reading material)Education (Reading material)Education (Video/audio tapes)Practice methods (Other mechanisms)Reminders (Mail)Reminders (Other mechanisms)


Tailored: YesGroup Setting: NoFeedback: YesPsychological: NoPrimary MD: No


Foot care education, behavioral contracts, andreinforcement (arm 2) resulted in 0.41 timesfewer serious foot lesions and more appropriatefoot care behavior (p=0.0001). Interventionsubjects (arm 2) were also more likely to havefoot examinations than were those in the usualcare group (arm 1) (68% vs. 28%, p<0.001).




176






1 Control (n/a)Education (One-on-one)Education (Reading material)Education (n/a)Feedback (n/a)



2 Education (One-on-one)Education (Reading material)Education (n/a)Feedback (Group meeting)Feedback (n/a)Practice self care skills (Group meeting)



McCulloch DK, 1983(#2264)

Diabetes (Type I)

RCT

Jadad Score: 2

Diagnostic criteria:HgbA1C


3 Education (One-on-one)Education (Reading material)Education (Video/audio tapes)Education (n/a)Feedback (n/a)



BMI (kg/m2) at 6 months:Arm 1 = 23.9 (2.3)Arm 2 = 23.7 (1.7)Arm 3 = 23.8 (2.0)

HbA1 (%) at 6 months:Arm 1 = 11.6 (0.9)Arm 2 = 10.6 (2.1)Arm 3 = 9.6 (2.3)




177






1 Education (Group meeting)Education (Reading material)Education (Video/audio tapes)Feedback (Group meeting)



2 Education (Group meeting)Feedback (Group meeting)Unstructured group time (Group meeting)



Mulrow C, 1987(#2266)

Diabetes (Type II)

RCT

Jadad Score: 2







Patient education utilizing videotapes (arm 1)had significant weight loss at 7 monthscompared to education without videotapes(arms 2 and 3), but changes were not sustainedat 11 months. There were no significantchanges in HbA1c.




178






1 Usual Care (n/a)



2 Education (Group meeting)Education (Reading material)



Pratt C, 1987(#2139)

Diabetes (Type II)

RCT

Jadad Score: 1


Comorbidities:n/a

3 Cognitive-behavioral (Group meeting)Education (Group meeting)Education (Reading material)Feedback (Group meeting)Goal setting (Group meeting)Social support (Group meeting)




No differences in weight or glycosylatedhemoglobin were noted between interventiongroups (arms 2 and 3) and usual care group(arm 1) at 8- or 16-week follow-up.




179






1 Counseling/therapy (One-on-one)Dietary monitoring (One-on-one)Education (One-on-one)Education (Reading material)



Rabkin SW, 1983(#2195)

Diabetes (Type II)

RCT

Jadad Score: 2


Comorbidities:Neuropathy andcholesterol andretinopathy

2 Cognitive-behavioral (Group meeting)Dietary monitoring (Group meeting)Education (Group meeting)




Patients attending a behavior modification group(arm 2) had greater weight loss than those inindividual counseling (arm 1) at 12 weeksfollow-up (p<0.05) but had higher triglyceridelevels (p<0.10). Fasting serum glucose was notappreciably different between groups.


1 Counseling/therapy (Office visit)Education (Hospitalization)Feedback (Office visit)


Tailored: YesGroup Setting: NoFeedback: YesPsychological: YesPrimary MD: n/a

Rainwater N, 1982(#2140)

Diabetes (Type II)

RCT

Jadad Score: 2


Comorbidities:Hypertension and

obesity

2 Cognitive-behavioral (Group meeting)Counseling/therapy (Office visit)Education (Group meeting)Feedback (Office visit)




Self-management participants (arm 2) hadcontinued weight loss at 2, 3 and 6-monthfollow-up, compared to those receivingconventional treatment (arm 1), who, onaverage, gained weight. Fasting blood glucosesignificantly decreased for both groups overtime but was not significantly different betweengroups. Systolic and diastolic blood pressuresincreased in both groups over time but less sofor self-management subjects. Satisfactionmeasures showed no differences.

Follow-up times: 1 MO, 2 MO, 3 MO, 6 MO



180






1 Usual Care (n/a)



Raz I, 1988(#2141)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:FBS, HgbA1C, andPPBS

Comorbidities:n/a




Fasting glucose (mg/dl) at 12 months:Arm 1 = 201.0 (45.9)Arm 2 = 157.5 (59.9)

HbA1c (%) at 12 months:Arm 1 = 9.6 (4.6)Arm 2 = 8.0 (5.3)

Weight (kg) at 12 months:Arm 1 = 73.4 (25.0)Arm 2 = 73.4 (22.1)

Follow-up times: 4 MO, 8 MO, 12 MO1 Usual Care (n/a)



Rettig BA, 1986(#2270)


RCT

Jadad Score: 2


Comorbidities:n/a

2 Education (Group meeting)Education (Home visit)




Intervention subjects (arm 2) had no significantdifferences compared to usual care group (arm1) with respect to diabetes-relatedhospitalizations over a 12-month period.Similarly, length of hospitalization, emergencyroom visits, and physician visits were nodifferent between groups despite significantgains for intervention subjects in self-careknowledge and skills in individual subject areasas well as in aggregate (p<0.001).

Follow-up times: 6 MO, 1 YR



181






1 Usual Care (n/a)



Sadur C N, 1999(#1668)


CCT

Jadad Score: 0

Diagnostic criteria:HgbA1C andRegistry

Comorbidities:n/a

2 Clinical reviews w/patient (Telephone)Cognitive-behavioral (One-on-one)Consultation w/specialists (Groupmeeting)Counseling/therapy (One-on-one)Education (Group meeting)Referrals (Group meeting)




At 6 months, HbA1c levels decreased 1.3% forintervention subjects (arm 2) as compared to0.22% for usual care group (arm 1). Interventionlevels persisted at 12 months but control levelshad fallen to similar levels by then as well. Self-care practices, self-efficacy, and satisfactionwith diabetes care were also greater forintervention subjects compared with usual caregroup.




182






1 Control (n/a)Counseling/therapy (n/a)



2 Counseling/therapy (n/a)






Stevens J, 1985(#2208)

Diabetes (Type II)

RCT

Jadad Score: 1







Patients in all groups were consulted by anutritionist. Three intervention groups (arms 2,3, and 4) received dietary plans that differed inrecommendations for fiber and oat bran intake.These groups demonstrated decreased bodyweight at 6-week follow-up for the oat brangroup (arm 4) compared to controls (arm 1)(p<0.05). Glycosylated hemoglobin decreasedin all 3 dietary groups but only in the increasedfiber group (arm 3) was this differencestatistically significant compared with controls(p<0.05).




183









Vanninen E, 1992(#2174)

Diabetes (Type II)

RCT

Jadad Score: 2


Comorbidities:Heart disease,hypertension,obesity, tobaccoabuse, andcholesterol

2 Education (Office visit)Education (One-on-one)Education (Reading material)Exercise program (Self-delivery)Feedback (One-on-one)


Tailored: YesGroup Setting: NoFeedback: YesPsychological: NoPrimary MD: Yes

BMI (kg/m2) at 12 months:Arm 1 = 32.1 (4.5)Arm 2 = 31.4 (5.1)


HbA (%) at 12 months:Arm 1 = 7.3 (1.6)Arm 2 = 6.6 (1.6)


1 Usual Care (n/a)



Vinicor F, 1987(#892)


RCT

Jadad Score: 2

Diagnostic criteria:FBS and PPBS

Comorbidities:Heart disease,hypertension, kidneydisease, neuropathy,obesity, CHF, and

2 Contracts (One-on-one)Education (Computer program)Education (Home visit)Education (One-on-one)Reminders (Telephone)




Significant improvements for patients receivingeducation (arm 2) were noted in HbA1c, fastingplasma glucose, weight and blood pressure, butgreatest improvements were noted in the groupreceiving both patient and physician education(arm 4).




184






3 Consultation w/specialists (Telephone)Education (Detailed reading material)Education (Group meeting)Education (Protocols)Feedback (Group meeting)Practice methods (Group meeting)Reminders (Computer program)



cholesterol

4 Consultation w/specialists (Telephone)Contracts (One-on-one)Education (Computer program)Education (Detailed reading material)Education (Group meeting)Education (Home visit)Education (One-on-one)Education (Protocols)Feedback (Group meeting)Practice methods (Group meeting)Reminders (Computer program)Reminders (Telephone)





185






1 Control (n/a)Education (Group meeting)Education (Reading material)



Ward WK, 1985(#2152)


RCT

Jadad Score: 1


Comorbidities:n/a

2 Education (Group meeting)Education (Reading material)Feedback (Group meeting)




Thirty minutes of professional instruction forself-monitoring blood glucose with Chem-stripbG (arm 2) compared with reading packageinstructions and practice (arm 1) resulted only ina lower percent error in blood glucoseestimation (p<0.02).


1 Usual Care (n/a)



Weinberger M, 1995(#896)

Diabetes (Type II)

RCT

Jadad Score: 2


Comorbidities:n/a

2 Clinical reviews w/patient (Telephone)Education (Telephone)Feedback (Telephone)Practice methods (Detailed reading

material)Practice methods (Telephone)Referrals (Telephone)



Fasting blood glucose (mg/dl) at 12 months:Arm 1 = 193.1 (57.9)Arm 2 = 174.1 (59.0)

Glycohemoglobin (%) at 12 months:Arm 1 = 11.1 (2.4)Arm 2 = 10.5 (2.7)




186






1 Usual Care (n/a)



Werdier JD, 1984(#2401)

Diabetes (Type II)

CCT

Jadad Score: 0


Comorbidities:n/a

2 Counseling/therapy (One-on-one)




Subjects receiving diabetes counseling (arm 2)had significant reductions in post-prandial bloodglucose compared with usual care group (arm1) (p=0.009) at 6-month evaluation.


1 Control (n/a)Counseling/therapy (One-on-one)Education (Group meeting)



White N, 1986(#2154)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:FBS and PPBS


2 Emotional support (Group meeting)Feedback (Group meeting)



Glycohemoglobin (%) at 6 months:Arm 1 = 10.1 (3.0)Arm 2 = 9.2 (2.0)

Overweight (%) at 6 months:Arm 1 = 45.0 (16.0)Arm 2 = 34.0 (28.0)

Serum glucose (mg/dl) at 6 months:Arm 1 = 243.0 (120.0)Arm 2 = 161.0 (48.0)




187






1 Contracts (Group meeting)Education (Group meeting)Financial incentives (Group meeting)


Tailored: NoGroup Setting: YesFeedback: YesPsychological: NoPrimary MD: n/a

2 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Dietary monitoring (Group meeting)Education (Group meeting)Exercise program (Group meeting)Financial incentives (Group meeting)Group Competition (Other mechanisms)



Wing RR/Epstein LH,1985(#2156)

Diabetes (Type II)

RCT

Jadad Score: 1

Diagnostic criteria:FBS and GTT

Comorbidities:Hypertension andobesity

3 Contracts (Group meeting)Education (Group meeting)Education (Reading material)Financial incentives (Group meeting)




Patients randomized to a behavior modificationgroup (arm 2) lost more weight than nutritioneducation (arm 3) or standard care (arm 1)groups during a 4-month treatment period(p<0.01). However, 16 months later, differencesin weight loss across these 3 groups were notsignificant.




188






1 Cognitive-behavioral (Group meeting)Dietary monitoring (Group meeting)Financial incentives (Group meeting)



Wing RR/Epstein LH,1986(#2158)

Diabetes (Type II)

RCT

Jadad Score: 2



2 Cognitive-behavioral (Group meeting)Dietary monitoring (Group meeting)Education (Group meeting)Financial incentives (Group meeting)




Two groups of randomized patients: a standardbehavioral weight control program (arm 1) and aweight control program that included self-monitoring of blood glucose and instruction inthe relationship between weight and glucoselevels (arm 2), both demonstrated significantweight loss (mean of 6.3 +/- 4.0 kg) at 12 weeksbut with no difference between groups.Significance was not maintained at one year.Nor were there any differences between groupsfor glycosylated hemoglobin, fasting bloodglucose, total cholesterol, blood pressure,medication use, or depression scores.




189






1 Control (n/a)Dietary monitoring (Group meeting)Education (Group meeting)Financial incentives (Group meeting)Follow up (Group meeting)Goal setting (Group meeting)Material incentive (Group meeting)Practice self care skills (Group meeting)



Wing RR, 1988(#2283)

Diabetes (Type II)

RCT

Jadad Score: 2

Diagnostic criteria:NDDG


2 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Dietary monitoring (Group meeting)Education (Group meeting)Feedback (Group meeting)Financial incentives (Group meeting)Follow up (Group meeting)Goal setting (n/a)Material incentive (Group meeting)Practice self care skills (Group meeting)Reminders (Group meeting)




After a 16-week treatment program, both self-regulation group (arm 2) and monitoring onlygroup (arm 1) significantly improved inbiochemical and weight measures but with nodifferences between arms. Though weight losswas significant for both arms at one-year follow-up, lack of difference between arms remained.HgbA1c values were unchanged in both armscompared to pretreatment values.

Follow-up times: 16 WK, 1 YR



190






1 Usual Care (n/a)



2 Education (Computer program)



3 Education (Computer program)Feedback (Computer program)



Wise PH, 1986(#2205)


CCT

Jadad Score: 1


Comorbidities:n/a

4 Education (Computer program)Education (Self-delivery)Feedback (Computer program)




Significant decreases in HbA1c levels wereseen for individuals participating in computer-based interactive teaching programs withfeedback (arm 2) compared with usual caregroup (arm 1) (p<0.05). Knowledge increased inthese groups as well.




191






1 Control (n/a)Education (Hospitalization)



Wood ER, 1989(#2159)

Diabetes (n/a)

CCT

Jadad Score: 1


Comorbidities:n/a

2 Education (Group meeting)Education (Hospitalization)Feedback (Group meeting)Practice self care skills (Group meeting)




Hospitalized patients receiving a comprehensiveinpatient diabetes education program (arm 2)had better compliance compared with controlgroup (arm 1) at 4-month follow-up with regardto self-care behaviors including exercise, insulinadministration and diet, however only exercisereached statistical significance (p=0.05). Bloodglucose was also lower (p=0.10) as was thenumber of emergency room visits (20 forcontrols versus 2 in experimental program,p=0.005).




192






1 Clinical reviews w/patient (Office visit)Education (Office visit)Self monitoring (Self-delivery)






Worth R, 1982(#2198)

Diabetes (Type I)

RCT

Jadad Score: 2

Diagnostic criteria:Insulin by regularurine test

Comorbidities:n/a





The method of monitoring diabetic control hadno effect on glycosylated hemoglobin,postprandial blood glucose, serum cholesterol,or body weight.



193

Evidence Table 2: Osteoarthritis






1 Usual Care (n/a)



Barlow JH, 2000(#3274)

Osteoarthritis(OA and RA)

RCT

Jadad Score: 2


Comorbidities:n/a

2 Cognitive-behavioral (Group meeting)Education (Group meeting)Education (Instructional manuals)Follow up (Group meeting)Goal setting (Group meeting)Practice self care skills (Group meeting)



Functioning (modified Health AssessmentQuestionnaire (0-3)) at 4 months:

Arm 1 = 1.4 (1.0)Arm 2 = 1.4 (1.0)

Pain (VAS (0-10)) at 4 months:Arm 1 = 6.4 (2.5)Arm 2 = 6.4 (2.5)


Evidence Table 2: Osteoarthritis (con't)


194






1 Usual Care (n/a)



2 Advocacy training (Group meeting)Arthritis self-management (Groupmeeting)Arthritis self-management (Instructionalmanuals)Arthritis self-management (Office visit)



Cohen J L, 1986(#770)

Osteoarthritis(OA, RA and other,NOS)

RCT

Jadad Score: 2


Comorbidities:n/a

3 Education (Group meeting)Education (Instructional manuals)




Though knowledge of arthritis and use ofexercise increased for both intervention groupscompared with no intervention, delivery byprofessional compared with layperson resultedin no differences with respect to pain,depression, physical function, social support ornon-exercise behaviors.


1 Clinical reviews w/patient (One-on-one)



Doyle TH, 1982(#2427)

Osteoarthritis (OA only)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Clinical reviews w/patient (Group meeting)




After 20 weeks of treatment, improvement wasseen for pain and range of motion in both armswith no difference seen between groups.




195






1 Usual Care (n/a)



2 Contracts (Group meeting)Education (Group meeting)



Goeppinger J, 1989(#801)


RCT

Jadad Score: 1


Comorbidities:n/a

3 Contracts (Group meeting)Education (Group meeting)Education (Reading material)Education (Video/audio tapes)



Functioning (Health Assessment Questionnairedisability score (0-3)) at 4 months:

Arm 1 = 1.0 (0.6)Arm 2 = 1.0 (0.6)Arm 3 = 1.1 (0.6)

Pain (Pain Index) at 4 months:Arm 1 = 25.7 (8.7)Arm 2 = 25.4 (8.7)Arm 3 = 26.6 (8.7)


1 Cognitive-behavioral (Group meeting)Education (Reading material)



Keefe F, 1996(#2082)


RCT

Jadad Score: 1


Comorbidities:n/a

2 Cognitive-behavioral (Group meeting)Counseling/therapy (Group meeting)Education (Reading material)




Patients receiving spouse-assisted coping skillstraining (arm 2) had lower levels of pain andpsychological disability and higher self-efficacyand more frequent use of pain-coping strategiesafter 10 weeks of treatment than did thosereceiving the cognitive-behavioral intervention(arm 1). Subjects in the pain-coping skillstraining without spouse assistance (arm 3) hadhigher self-efficacy, coping, and maritaladjustment and lower pain and psychological



196









disability as compared to the cognitive-behavioral group.


1 Usual Care (n/a)



2 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Video/audio tapes)Consultation w/specialists (Groupmeeting)Counseling/therapy (Telephone)



Keefe F J, 1990a(#907)


RCT

Jadad Score: 1

Diagnostic criteria:X-ray and MD


3 Counseling/therapy (Telephone)Education (Group meeting)


Tailored: NoGroup Setting: YesFeedback: NoPsychological: YesPrimary MD: No

Functioning (AIMS physical disability scale) at 6months:

Arm 1 = 2.0 (1.3)Arm 2 = 2.1 (1.3)Arm 3 = 2.3 (1.3)

Pain (AIMS pain scale) at 6 months:Arm 1 = 5.7 (1.6)Arm 2 = 5.7 (1.7)Arm 3 = 4.6 (1.7)




197






1 Usual Care (n/a)



2 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Video/audio tapes)Consultation w/specialists (Groupmeeting)



Keefe F J, 1990b(#908)


RCT

Jadad Score: 1






Duplicate population Keefe F J, 1990b

Patients who received pain coping skills training(arm 2) had significantly lower levels of pain(p<0.01) and psychological disability (p<0.001)than those who received arthritis education (arm3) or usual care (arm 1). Physical disability wasno different between groups after treatment.




198






1 Usual Care (n/a)



2 Education (Reading material)









Laborde JM, 1983(#2355)


RCT

Jadad Score: 1

Diagnostic criteria:Chart review and

self report

Comorbidities:n/a





Subjects receiving relaxation procedures (arm4) had significantly less pain than thosereceiving other interventions or those in thecontrol group (p<0.05). No differences werenoted with respect to stiffness, mobility,medication taking behavior, or knowledge.




199






1 Usual Care (n/a)



Lorig K, 1985(#835)


RCT

Jadad Score: 1


Comorbidities:n/a

2 Arthritis self-management (Groupmeeting)



Functioning (Disability (0-3)) at 4 months:Arm 1 = 0.5 (1.0)Arm 2 = 0.6 (1.0)

Pain (VAS (0-10)) at 4 months:Arm 1 = 3.2 (2.5)Arm 2 = 3.4 (2.5)


1 Usual Care (n/a)






Lorig K, 1986(#830)

Osteoarthritis (OA andRA)

RCT

Jadad Score: 2


Comorbidities:n/a 3 Arthritis self-management (Group

meeting)



Functioning (Health Assessment Questionnaire(0-3)) at 4 months:

Arm 1 = 0.9 (1.0)Arm 2 = 0.8 (1.0)Arm 3 = 0.7 (1.0)

Pain (Double anchored VAS (0-15)) at 4months:

Arm 1 = 7.3 (3.8)Arm 2 = 8.9 (3.8)Arm 3 = 7.4 (3.8)




200






1 Usual Care (n/a)



Lorig K, 1989(#837)


RCT

Jadad Score: 1


Comorbidities:n/a




Functioning (Stanford Health AssessmentQuestionnaire (0-3)) at 4 months:

Arm 1 = 0.7 (1.0)Arm 2 = 0.7 (1.0)

Pain (Double anchored VAS (0-10)) at 4months:

Arm 1 = 4.5 (2.5)Arm 2 = 4.2 (2.5)


1 Usual Care (n/a)



Lorig K R, 1999(#608)

Osteoarthritis(Arthritis, NOS)

RCT

Jadad Score: 2


Comorbidities:Heart disease,chronic respiratorydisease, CHF, andstroke

2 Cognitive-behavioral (Group meeting)Education (Group meeting)Feedback (Group meeting)Practice methods (Group meeting)



Functioning (modified Health AssessmentQuestionnaire disability score (0-3)) at 6months:

Arm 1 = 0.9 (1.0)Arm 2 = 0.8 (1.0)

Pain (adaptation of Medical Outcomes Studypain scale (0-100)) at 6 months:

Arm 1 = 56.8 (25.0)Arm 2 = 55.4 (25.0)




201






1 Usual Care (n/a)



2 Advocacy training (Telephone)Clinical reviews w/patient (Telephone)Reminders (Telephone)



3 Advocacy training (Office visit)Clinical reviews w/patient (Office visit)



Weinberger M, 1989(#430)


RCT

Jadad Score: 2


Comorbidities:n/a

4 Advocacy training (Office visit)Advocacy training (Telephone)Clinical reviews w/patient (Office visit)Clinical reviews w/patient (Telephone)Reminders (Telephone)




Education delivered by telephone (arms 2 and4) compared with no telephone (arms 1 and 3)resulted in improved physical health andreduced pain (p=0.02) with trends suggestingimproved psychological health (p=0.10).



202

Evidence Table 3: Post-Myocardial Infarction Care






1 Usual Care (n/a)



Burgess AW, 1987(#2652)

Myocardial infarction(Uncomplicated andcomplicated)

RCT

Jadad Score: 2

Diagnostic criteria:CPK-MB elevation,ECG, Symptoms

Comorbidities:CHF

2 Cognitive-behavioral (One-on-one)Follow up (Mail)Social support (One-on-one)



Death at 13 months:Arm 1 = 5 deathsArm 2 = 5 deaths

Return to work (% return to same or new job) at13 months:

Arm 1 = 88% of 76 eligible subjectsArm 2 = 88% of 77 eligible subjects


1 Usual Care (n/a)



DeBusk F, 1985(#2669)

Myocardial infarction(First occurrenceand reoccurrence)

RCT

Jadad Score: 2

Diagnostic criteria:CPK-MB elevation,ECG, SGOT,Symptoms

2 Control (n/a)Counseling/therapy (One-on-one)Exercise testing (n/a)




The average increase in functional capacity(i.e., peak treadmill workload on METS)between 3 and 26 weeks was significantlygreater (p<0.05) in training groups (arms2,3,4,5, and 6) than in the usual care group(arm 1) (1.8 vs. 1.2 METs, respectively).

Follow-up times: 3 WK, 11 WK, 26 WK

Evidence Table 3: Post-Myocardial Infarction Care (con't)


203






3 Counseling/therapy (One-on-one)Exercise diary (Self-delivery)Exercise monitoring (Telephone)Exercise program (One-on-one)Exercise program (Reading material)Exercise testing (n/a)Follow up (Telephone)






Comorbidities:n/a

5 Counseling/therapy (One-on-one)Exercise monitoring (Group meeting)Exercise program (Group meeting)Exercise testing (n/a)





204









1 Control (n/a)Counseling/therapy (Hospitalization)



DeBusk RF, 1994(#775)

Myocardial infarction(Angina withinfarction)

RCT

Jadad Score: 3

Diagnostic criteria:CPK-MB elevation,ECG, Chest pain,SGOT

Comorbidities:Tobacco abuse,substance abuse,and psychiatricproblems

2 Counseling/therapy (Computer program)Counseling/therapy (Hospitalization)Counseling/therapy (Office visit)Counseling/therapy (Reading material)Counseling/therapy (Telephone)Counseling/therapy (Video/audio tapes)Education (Hospitalization)Education (Office visit)Education (Telephone)Feedback (Mail)




At 12 months, 4.1% had died in the interventionarm (arm 2), compared to 3.4% in the controlgroup (arm 1). LDL and total cholesteroldecreased more in the intervention arm(p <0.001). Smoking cessation at 12 monthsincreased significantly for the case managementarm versus usual care (70% vs. 53%, p=0.03).Functional capacity was higher in theintervention arm at 6 months 9.3 METS vs. 8.4METS. The% consuming a low fat dietincreased from 31% to 88% at 90 days in theintervention arm but was similar to usual carearm.




205






1 Usual Care (n/a)



Dennis C, 1988(#2656)

Myocardial infarction(Uncomplicated MI)

RCT

Jadad Score: 3

Diagnostic criteria:CPK-MB elevation,ECG, MD

Comorbidities:n/a

2 Clinical reviews w/patient (Telephone)Consultation w/specialists (Mail)Consultation w/specialists (Telephone)Counseling/therapy (One-on-one)Exercise testing (One-on-one)


Tailored: YesGroup Setting: NoFeedback: YesPsychological: YesPrimary MD: Yes

Death at 6 months:Arm 1 = 2 deathsArm 2 = 1 death

Return to work (% working part- or full-time) at 6months:



1 Usual Care (n/a)



Frasure-Smith N,1985(#790)

Myocardial infarction(Uncomplicated,complicated, firstand reoccurrence,angina with infarctionand unspecified)

CCT

Jadad Score: 0


Comorbidities:Hypertension,obesity, DM, CHF,tobacco abuse, andangina

2 Consultation w/specialists (Groupmeeting)Education (Home visit)Psychological assessment/care (Homevisit)Psychological assessment/care(Telephone)




Nurse-delivered stress monitoring and stressreduction interventions resulted in lower stresslevels and fewer cardiac deaths (70% decrease)for intervention patients (arm 2) compared withusual care group (arm 1) but not reinfarctionrates. Differences between groups with respectto SES may be responsible for thesedifferences.




206






1 Usual Care (n/a)



Frasure-Smith N,1989(#2218)

Myocardial infarction(Uncomplicated,complicated, firstand reoccurrence)

CCT

Jadad Score: 1


Comorbidities:Hypertension,obesity, DM, tobaccoabuse, andcholesterol

2 Consultation w/specialists (Groupmeeting)Education (Home visit)Psychological assessment/care (Homevisit)Psychological assessment/care(Telephone)




Subjects receiving home-based nursinginterventions aimed at reducing stress (arm 2)had significantly fewer MI recurrences thanusual care subjects (arm 1) over a 4-year follow-up period (p=0.04). The difference in mortalitywas maximal at 18 months post-MI, but duringthe remaining years mortality between groupswas equivalent. No difference in hospitalizationreadmission rates was noted.

Follow-up times: 2 YR, 5 YR, 64 MO

1 Usual Care (n/a)



2 Counseling/therapy (Group meeting)



Friedman M, 1982(#2367)


CCT

Jadad Score: 0

Diagnostic criteria:CPK-MB elevation,ECG, Patient History

Comorbidities:Heart disease,hypertension, CHF,tobacco abuse, andcholesterol

3 Cognitive-behavioral (Group meeting)Counseling/therapy (Group meeting)




Subjects receiving interventions of bothcardiologic and behavioral counseling (arms 2and 3) had lower 1-yr rates of reinfarction(p<0.01) and death (p<0.05) than usual caresubjects (arm 1). Behavioral counseling (arm 3)resulted in fewer reinfarctions (1.1% versus3.3% p<0.05) than cardiologic counseling alone(arm 2).




207






1 Counseling/therapy (Group meeting)Psychological assessment/care (Groupmeeting)



Friedman M, 1984(#2362)


RCT

Jadad Score: 1

Diagnostic criteria:CPK-MB elevation,ECG, Clinical history

Comorbidities:Heart disease,hypertension, CHF,and tobacco abuse

2 Cognitive-behavioral (Group meeting)Counseling/therapy (Group meeting)




Patients receiving Type A behavioral counseling(arm 2) had a 7.2% 3-year cumulative cardiacrecurrence rate compared with 13% forindividuals receiving only cardiologic counseling(arm 1) (p<0.005). Three-year survival withoutcardiac recurrence was also higher for thebehavioral counseling group (p<0.01) but nodifferences were noted for arrhythmias orhypertension.


1 Usual Care (n/a)



2 Exercise program (Hospitalization)Feedback (Office visit)



Froelicher E S, 1994(#792)

Myocardial infarction(Uncomplicated MI)

RCT

Jadad Score: 2


Comorbidities:n/a

3 Counseling/therapy (Group meeting)Education (Group meeting)Exercise program (Hospitalization)Feedback (Office visit)



Death at 24 weeks:Arm 1 = 2 deathsArm 2 = 3 deathsArm 3 = 3 deaths

Return to work (% return to same job) at 24weeks:

Arm 1 = 90% of 62 eligible subjectsArm 2 = 95% of 63 eligible subjectsArm 3 = 98% of 52 eligible subjects




208






1 Usual Care (n/a)



Gruen W, 1975(#2360)

Myocardial infarction(Uncomplicated,complicated, firstoccurrence, andunspecified)

CCT

Jadad Score: 0


Comorbidities:CHF, anxiety anddepression

2 Advocacy training (One-on-one)Psychological assessment/care (One-on-one)




Intervention subjects (arm 2) had 2.5 fewerhospital days (p<0.05), less observed weaknessand depression (p<0.05), decreased anxiety(p<0.001), and fewer supraventriculararrhythmias (p<0.05) compared with usual carepatients (arm 1). No differences in chest painoccurrence were noted.


1 Usual Care (n/a)



Heller R F, 1993(#809)

Myocardial infarction(Uncomplicated, firstand reoccurrence,angina with andwithout infarction,and unspecified)

RCT

Jadad Score: 1


Comorbidities:Heart disease,hypertension,obesity, tobaccoabuse, angina, andcholesterol

2 Contracts (Reading material)Education (Mail)Education (Reading material)Feedback (Reading material)Reminders (Other mechanisms)




Return to work (% return to same job) at 6months:





209






1 Control (n/a)Education (Video/audio tapes)



Horlick L, 1984(#2219)

Myocardial infarction(Uncomplicated,complicated, firstand reoccurrence,and unspecified)

RCT

Jadad Score: 1


Comorbidities:CHF, anxiety anddepression

2 Education (Group meeting)Education (One-on-one)Education (Video/audio tapes)Unstructured group time (Group meeting)



Death at 6 months:Arm 1 = 1 deathArm 2 = 6 deaths

Return to work (% working part- or full-time) at6 months:

Arm 1 = 92.8% of 29 eligible subjectsArm 2 = 80.6% of 65 eligible subjects


1 Control (n/a)Counseling/therapy (Home visit)Counseling/therapy (Office visit)Counseling/therapy (Telephone)Education (Reading material)



Lewin B, 1992(#827)


RCT

Jadad Score: 4

Diagnostic criteria:WHO

Comorbidities:Tobacco abuse

2 Counseling/therapy (Home visit)Counseling/therapy (Office visit)Counseling/therapy (Telephone)Education (Instructional manuals)Education (Video/audio tapes)




Anxiety and general emotional disturbancescores for intervention subjects (arm 2) werehalf that of controls (arm 1) at 1-year follow-up.In the first 6 months of study, 18 controlcompared with 6 intervention patients hadhospital admissions (p=0.02).

Follow-up times: 6 WK, 6 MO, 12 MO



210






1 Usual Care (n/a)



2 Control (n/a)Counseling/therapy (One-on-one)Exercise testing (n/a)



Miller NH, 1984(#2670)


RCT

Jadad Score: 2

Diagnostic criteria:CPK-MB elevation,ECG, SGOT,Symptoms

Comorbidities:n/a





Though functional capacity improved in patientsrandomized to either home (arms 3 and 4) orgroup (arms 5 and 6) exercise trainingcompared with controls (arms 1 and 2), nodifferences were seen between home and grouptraining. Frequency of exercise induced anginaor ischemic ST-segment depression was nodifferent between groups when measured at 26weeks.

Follow-up times: 3 WK, 11 WK, 26 WK






211












1 Usual Care (n/a)



2 Cognitive-behavioral (Video/audio tapes)Education (Video/audio tapes)


Tailored: NoGroup Setting: NoFeedback: NoPsychological: YesPrimary MD: n/a

Oldenburg B, 1985(#2699)

Myocardial infarction(First occurrence)

CCT

Jadad Score: 1


Comorbidities:Heart disease

3 Cognitive-behavioral (Video/audio tapes)Counseling/therapy (One-on-one)Education (Video/audio tapes)




Both intervention groups (arms 2 and 3) hadimproved psychological measures related toanxiety, distress, and Type A behavior,compared with the usual care group (arm 1)(p<0.05). The counseling group (arm 3)demonstrated sustained significant reductions inalcohol and tobacco consumption at 12-monthfollow-up. A higher proportion of counselingsubjects reported returning to work by 12months and a trend towards less chest pain andrelated hospital admissions was also seen.




212






1 Usual Care (n/a)



2 Education (One-on-one)Education (Video/audio tapes)



Oldenburg B, 1989(#2698)

Myocardial infarction(First occurrenceand reoccurrenceand unspecified)

RCT

Jadad Score: 1


Comorbidities:Heart disease andhypertension

3 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Education (One-on-one)Education (Video/audio tapes)Exercise program (Group meeting)




Subjects attending a behavioral group (arm 3)had statistically significantly less anxiety anddepression over 12-month follow-up than theusual care subjects (arm 1) (p<0.05). Type Abehavior was also reduced to a greater degreethan usual care or education interventionsubjects (p<0.01). Smoking decreased in allgroups but relapse rate for behavioral groupwas almost half that of the other 2 groups(p<0.05). The behavioral group also had fewerphysical symptoms and greater exercisecapacity (p<0.05).


1 Usual Care (n/a)



Oldridge N, 1991(#2653)


RCT

Jadad Score: 1

Diagnostic criteria:CPK-MB elevation,ECG, Symptoms

Comorbidities:n/a

2 Cognitive-behavioral (Group meeting)Education (Group meeting)Exercise program (Group meeting)




Return to work (% return to work) at 12 months:Arm 1 = 83.6% of 61 eligible subjectsArm 2 = 79.3% of 54 eligible subjects

Follow-up times: 8 WK, 4 MO, 8 MO, 12 MO



213






1 Usual Care (n/a)



2 Education (Hospitalization)Exercise program (Hospitalization)Exercise program (Office visit)Exercise program (Self-delivery)Feedback (Office visit)



Ott CR, 1983(#2657)


RCT

Jadad Score: 1

Diagnostic criteria:CPK-MB elevation,ECG, Clinical history

Comorbidities:Obesity and tobacco

abuse 3 Counseling/therapy (One-on-one)Education (Group meeting)Education (Hospitalization)Education (Reading material)Education (Self-delivery)Education (Video/audio tapes)Exercise program (Hospitalization)Exercise program (Office visit)Feedback (Office visit)




Same study population as Sivarajan, et al.,1983. Using the Sickness Impact Profile surveyinstrument, researchers found improvedphysical and psychosocial function for thosereceiving an exercise program coupled withcounseling about cardiac risk factors andemotional adjustment after myocardial infarction(arm 3). Differences between groups exceededany changes noted for those receiving anexercise-only intervention and were significantat a .01 to .05 level dependent upon specificmeasured categories.




214






1 Usual Care (n/a)



Payne T J, 1994(#859)


CCT

Jadad Score: 1

Diagnostic criteria:MD, Stress test

Comorbidities:Heart disease andanxiety anddepression

2 Cognitive-behavioral (Group meeting)Education (Group meeting)Practice self care skills (Self-delivery)




Chest pain frequency and depression scoreswere significantly lower for intervention subjects(arm 2) at 1-month follow-up but no differencesbetween intervention and usual care (arm 1)subjects were noted at 6-months.


1 Control (n/a)Counseling/therapy (Group meeting)



Powell LH, 1984(#2361)

Myocardial infarction(First andreoccurrence, anginawith infarction andunspecified)

RCT

Jadad Score: 2


Comorbidities:Heart disease,hypertension, andhypercholeterelemia

2 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Reading material)Counseling/therapy (Group meeting)




Behavioral counseling (arm 2) targeted to “TypeA” life style resulted in greater reductions inType A behavior compared with standardcounseling (arm 1). Cardiovascular recurrencerates were no different between counselinggroups but behavioral counseling subjects hadlower 2-year cardiovascular recurrences thancontrols (2.76 versus 6.00p<0.05) Total cholesterol and blood pressurewere similar between groups.




215






1 Control (n/a)Dietary monitoring (Office visit)Education (Reading material)



Rahe RM, 1979(#2406)

Myocardial infarction(First occurrenceand unspecified)

RCT

Jadad Score: 1


Comorbidities:Heart disease,hypertension,obesity, DM, CHF,and tobacco abuse

2 Cognitive-behavioral (Group meeting)Contracts (Group meeting)Counseling/therapy (Group meeting)Dietary monitoring (Office visit)Education (Group meeting)Education (Reading material)




Return to work (% who worked full-time beforeMI who returned to work) at 12 months:

Arm 1 = 41.7% of 12 eligible subjectsArm 2 = 94.1% of 17 eligible subjects


1 Usual Care (n/a)



Schulte MB, 1986(#2438)

Myocardial infarction(First occurrence andunspecified)

CCT

Jadad Score: 0


Comorbidities:n/a

2 Education (Group meeting)Practice methods (Group meeting)Practice methods (Video/audio tapes)Practice self care skills (Group meeting)




Intervention subjects (arm 2) demonstrateddecreased anxiety (p<0.05) and increased selfcare cardiac skills (p<0.01) compared with usualcare subjects (arm 1).




216






1 Usual Care (n/a)



2 Education (Hospitalization)Exercise program (Hospitalization)Exercise program (Office visit)Exercise program (Self-delivery)Feedback (Office visit)



Sivarajan ES, 1983(#2439)


RCT

Jadad Score: 1

Diagnostic criteria:CPK-MB elevation,

ECG, Clinical history

Comorbidities:Obesity and tobacco

abuse 3 Counseling/therapy (One-on-one)Education (Group meeting)Education (Hospitalization)Education (Reading material)Education (Self-delivery)Education (Video/audio tapes)Exercise program (Hospitalization)Exercise program (Office visit)Feedback (Office visit)




Same study population as Ott, et al., 1983.Though modest changes in diet were noted forintervention subjects (arms 2 and 3), nochanges occurred between groups with respectto weight or smoking.




217






1 Usual Care (n/a)



2 Exercise program (Group meeting)



Stern MJ, 1983(#2377)

Myocardial infarction(Unspecified)

RCT

Jadad Score: 1


Comorbidities:Hypertension andtobacco abuse 3 Counseling/therapy (Group meeting)



Death at 12 months:Arm 1 = 1 deathArm 2 = 0 deathsArm 3 = 0 deaths

Return to work (% who returned who hadn'treturned by baseline) at 12 months:

Arm 1 = 0% of 5 eligible subjectsArm 2 = 60% of 5 eligible subjectsArm 3 = 33.3% of 9 eligible subjects

Follow-up times: 3 MO, 6 MO, 1 YR

1 Usual Care (n/a)



Turner L, 1995(#887)

Myocardial infarction(Unspecified)

RCT

Jadad Score: 1


Comorbidities:Hypertension,tobacco abuse, andCABG and highcholesterol

2 Cognitive-behavioral (Group meeting)Reminders (Group meeting)


Tailored: NoGroup Setting: YesFeedback: YesPsychological: YesPrimary MD: No


Subjective distress decreased in the stressmanagement group (arm 2) as compared to theusual care group (arm 1). This study lackedsignificant statistical power to detect potentiallymeaningful between-group differences.



218

Evidence Table 4: Hypertension






1 Usual Care (n/a)



2 Dietary monitoring (Self-delivery)Exercise program (Group meeting)



Blumenthal JA, 1991(#752)

Hypertension(Essential, Systolicand Diastolic,Treated andUntreated)

RCT

Jadad Score: 1

Diagnostic criteria:MD and bloodpressure recordings

Comorbidities:n/a

3 Dietary monitoring (Self-delivery)Exercise program (Group meeting)



Diastolic BP (mmHg) at 16 weeks:Arm 1 = 90 (6.2)Arm 2 = 89 (6.8)Arm 3 = 89 (6.4)

Systolic BP (mmHg) at 16 weeks:Arm 1 = 133 (8.6)Arm 2 = 133 (10.4)Arm 3 = 136 (11.6)


1 Usual Care (n/a)



Given C, 1984(#2309)

Hypertension(Systolic anddiastolic, Treated,and Medicationtreatment)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Cognitive-behavioral (One-on-one)Cognitive-behavioral (Prescription)Education (Instructional manuals)Education (One-on-one)Feedback (One-on-one)



Diastolic BP (mmHg) at 24 weeks:Arm 1 = 91.4 (5.6)Arm 2 = 87.1 (7.1)

Systolic BP (mmHg) at 24 weeks:Arm 1 = 138.0 (8.9)Arm 2 = 135.1 (12.9)


Evidence Table 4: Hypertension (con't)


219






1 Control (n/a)Blood pressure monitoring (Self-delivery)Self monitoring (Self-delivery)



2 Blood pressure monitoring (Self-delivery)Medication therapy (n/a)Self monitoring (Self-delivery)



3 Blood pressure monitoring (Self-delivery)Cognitive-behavioral (n/a)Self monitoring (Self-delivery)


Tailored: NoGroup Setting: NoFeedback: NoPsychological: YesPrimary MD: No

Goldstein IB, 1982(#2466)


RCT

Jadad Score: 1

Diagnostic criteria:Blood pressure

recordings


4 Blood pressure monitoring (Self-delivery)Nontraditional therapies (One-on-one)Self monitoring (Self-delivery)



Diastolic BP (mmHg) at 8 weeks:Arm 1 = 98.8 (6.7)Arm 2 = 92.6 (6.7)Arm 3 = 100.6 (6.7)Arm 4 = 92.9 (6.7)

Systolic BP (mmHg) at 8 weeks:Arm 1 = 144.7 (12.4)Arm 2 = 129.4 (12.4)Arm 3 = 152.3 (12.4)Arm 4 = 145 (12.4)

Follow-up times: 2 WK, 4 WK, 6 WK, 8 WK, 3MO, 4 MO, 5 MO



220






1 Usual Care (n/a)



2 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Self-delivery)



Hafner RJ, 1982(#2467)

Hypertension(Essential, Systolicand Diastolic,Treated)

RCT

Jadad Score: 1


Comorbidities:n/a

3 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Self-delivery)Nontraditional therapies (Group meeting)



Diastolic BP (mmHg) at 20 weeks:Arm 1 = 96.3 (6.7)Arm 2 = 88.2 (6.7)Arm 3 = 91.9 (6.7)

Systolic BP (mmHg) at 20 weeks:Arm 1 = 150.5 (12.4)Arm 2 = 132.9 (12.4)Arm 3 = 139.2 (12.4)

Follow-up times: 8 WK, 3 MO, 5 MO



221






1 Usual Care (n/a)



2 Cognitive-behavioral (One-on-one)Feedback (One-on-one)Practice self care skills (Self-delivery)Psychological assessment/care (One-on-one)



3 Feedback (One-on-one)Practice self care skills (Self-delivery)Psychological assessment/care (Groupmeeting)



Hoelscher TJ, 1986(#2457)


RCT

Jadad Score: 1


recordings

Comorbidities:n/a

4 Contracts (Group meeting)Contracts (Telephone)Feedback (One-on-one)Practice self care skills (Self-delivery)Psychological assessment/care (Groupmeeting)



Diastolic BP (mmHg) at 9-10 week:Arm 1 = 95.6 (6.7)Arm 2 = 91.6 (9.0)Arm 3 = 89.5 (6.9)Arm 4 = 87.5 (5.9)

Systolic BP (mmHg) at 9-10 week:Arm 1 = 146.9 (18.4)Arm 2 = 138.1 (13.6)Arm 3 = 135.7 (9.4)Arm 4 = 140.3 (10.6)




222






1 Control (n/a)Education (One-on-one)Exercise program (One-on-one)Nontraditional therapies (One-on-one)



Irvine MJ, 1986(#2458)

Hypertension(Diastolic, Treatedand untreated,Medicationtreatment)

RCT

Jadad Score: 1


recordings

Comorbidities:n/a

2 Cognitive-behavioral (One-on-one)Education (One-on-one)Nontraditional therapies (One-on-one)




At 6-month follow up, significantly greaterdecreases were seen for both systolic BP anddiastolic BP in the relaxation arm (arm 2)compared with control arm (arm 1) (p<0.01,p<0.05, respectively).


1 Usual Care (n/a)



Jacob RG, 1985(#2459)

Hypertension(Systolic anddiastolic, Untreated,No medicationtreatment)

RCT

Jadad Score: 1


recordings

Comorbidities:Obesity and

cholesterol

2 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Video/audio tapes)Dietary monitoring (Self-delivery)Education (Group meeting)Financial incentives (Group meeting)Practice self care skills (Self-delivery)Reminders (Group meeting)





Follow-up times: 2 MO, 6 MO, 7 MO, 1 YR



223






1 Usual Care (n/a)



Jorgensen RS, 1981(#2452)

Hypertension(Essential, Treated,and Medicationtreatment)

RCT

Jadad Score: 1


Comorbidities:n/a

2 Cognitive-behavioral (Group meeting)Cognitive-behavioral (Video/audio tapes)Feedback (Group meeting)Follow up (Group meeting)Practice self care skills (Group meeting)








224






1 Control (n/a)Placebo medication (n/a)



2 Blood pressure lowering medication (n/a)



Kostis JB, 1992(#2472)


RCT

Jadad Score: 2


recordings

Comorbidities:n/a

3 Cognitive-behavioral (Group meeting)Dietary monitoring (Self-delivery)Education (Group meeting)Exercise program (Self-delivery)Goal setting (Group meeting)Social support (Group meeting)








225






1 Usual Care (n/a)



2 Dietary monitoring (Self-delivery)Education (Group meeting)Exercise program (Self-delivery)



Lagrone R, 1988(#2460)


RCT

Jadad Score: 1


recordings


3 Cognitive-behavioral (Group meeting)Dietary monitoring (Self-delivery)Education (Group meeting)Exercise program (Self-delivery)


Tailored: NoGroup Setting: YesFeedback: NoPsychological: YesPrimary MD: No




1 Usual Care (n/a)



Leveille SG, 1998(#1175)

Hypertension(Not specified)

RCT

Jadad Score: 2


Comorbidities:Heart disease, DM,arthritis, tobaccoabuse, and cancerand stroke

2 Education (Group meeting)Education (Instructional manuals)Education (Reading material)Follow up (One-on-one)Follow up (Telephone)Goal setting (One-on-one)



The intervention group (arm 2) had fewerdisability days and less self-reported functionaldecline but there were no differences based onphysical performance tests when compared withthe usual care group (arm 1). The number ofinpatient days was significantly less forintervention subjects (33 days versus 116 daysfor usual care group, p=0.049). Interventionsubjects also had greater physical activity(p=0.03) and less psychoactive medication use(p=0.04) than usual care group.



226






1 Usual Care (n/a)



2 Counseling/therapy (One-on-one)



3 Education (One-on-one)



4 Cognitive-behavioral (Group meeting)



5 Counseling/therapy (One-on-one)Education (One-on-one)



Morisky DE, 1983(#2304)

Hypertension(Systolic anddiastolic)

RCT

Jadad Score: 1


Comorbidities:Heart disease,kidney disease, DM,and CHF

6 Cognitive-behavioral (Group meeting)Counseling/therapy (One-on-one)




Study subjects assigned to any of theexperimental groups had a 30% improvement inblood pressure control at 2 years and a 70%improvement at 5 years compared to 22% forthe usual care group with no difference inweight control or compliance in appointments.There was a 57% reduction in the 5-year all-cause mortality for intervention subjectscompared to those receiving usual care(p<0.05).

Follow-up times: 2 YR, 5 YR



227






Morisky DE, 1983(#2304)continued

7 Cognitive-behavioral (Group meeting)Education (One-on-one)



8 Cognitive-behavioral (Group meeting)Counseling/therapy (One-on-one)Education (One-on-one)



1 Usual Care (n/a)



Southam MA, 1982(#2453)


RCT

Jadad Score: 2



2 Cognitive-behavioral (One-on-one)Cognitive-behavioral (Video/audio tapes)





Follow-up times: 9 WK, 6 MO



228






1 Control (n/a)Practice methods (Protocols)



2 Counseling/therapy (One-on-one)Feedback (One-on-one)Practice methods (Protocols)



Taylor CB, 1977(#2464)


RCT

Jadad Score: 2

Diagnostic criteria:Blood pressurerecordings andRoutinehypertension workup

Comorbidities:n/a

3 Cognitive-behavioral (One-on-one)Cognitive-behavioral (Video/audio tapes)Feedback (One-on-one)Practice methods (Protocols)





Follow-up times: 8 WK, 6 MO


229

Evidence Table 5. Cost Articles

Articlenumber

Author/Year

Subjects (S), Follow-up period (F/U),Research design (D)and settings (ST)

Interventions Costs ofintervention

Effectiveness Health care costs orutilizations

C/E Ratings

Diabetes2270 Rettig et

al.,1986

S : 393 type1 and type2 diabetic patientsrecruited from amongdiabetic inpatients(mean = 52, 67%female)F/U: 6 and 12 monthsD: RCTST: Patient home

I: Needs assessmentand tailored individualinstruction at patienthome by a trained RNor LPN from homehealth nursingagencies.C: Usual care

Not reported, butinvolving 4-dayintensive course indiabetes self-care forparticipating nurses,and several homevisits (no more than12 for eachindividual).

At 6 months, interventionsubjects showedsignificantly greater self-careknowledge and skills thancontrol, although the actualdifferences in self-care skillswere probably too small tohave any practical meaning.No differences between thegroups were noted after 12mo of F/U.

At 6 and 12 months, nodifference was foundbetween control andintervention subjects interms of diabetes-relatedhospitalizations, length ofhospital stay, footproblems, emergencyroom and physician visits,and sick days.

Not cost-effective.

2159 Wood,1989

S: 93 hospitalizedpatients with type 1 or2 diabetes, age 20 to75 years old (mean 60,53% female).F/U: 1 mo, and 4months.D: RCTST: Hospital

I: Inpatient groupeducation programwhich stressed bothknowledge and self-help behaviors.C: Usual care

Not reported, buteach patient attendedtwo days of 2-houreducation program,with an averageattendance of four tosix patients. The 1st

session was taughtby a nurse educator,and the 2nd by aregistered dietitianand a communityhealth nurse.

Based on self-report. At 4month f/u, all respondentsreported a decline inperforming self-carebehaviors in comparisonwith the 1-month f/u.Compliance was lower forthe control group.Intervention group showedsignificantly bettercompliance than control inregards to exercise, diet,administering insulin, andbetter outcome measuresrelating to improvedmetabolic control andsignificant reduction in bloodsugar levels.

The intervention groupexperienced a significantlylower emergency roomvisitation rate (p <.005): At4 months, the 40 controlpatients reported 20 ERvisits, and the 53intervention patientsreported 2 ER visits. Thecontrol patients reported18 hospital readmission,and the interventionpatients reported 8hospital readmission.

Likely to becost-savings.

2589 deWeerdtet al.,1991

S : 558 insulin-treateddiabetic patients age18-65 years old (mean= 45)F/U : 6 monthsD: RCTST: 15 hospitals in

I: 1) Collaborativegroup education led byhealth-care worker(HCW), 2) Sameeducation led by fellowpatientsC: Usual care

Direct costs of theeducation program(including the costs ofemploying theeducators) andindirect costs (costsof the hours spent by

No significant effect ofeducation program onmetabolic control or qualityof life.

No significant effect ofeducation program oncosts of using healthservices (although theexperimental groupsshowed a trend to adecrease in the length of

Not cost-effective.Possiblereasonsinclude thequality of theeducation

Evidence Table 5: Cost Articles (con't)


230

Netherlands (5 forcontrol)

the participants inattending theeducation) togetherequal to US$100 perpatient (1990 dollar).Adding the cost ofdevelopingeducational materialsmake the per-patientcost to US$144 (1990dollar). No differencebetween I1 and I2.

hospitalization, but it wasnot significant). Almostequal changes in thenumber of visits to thephysician and GP werefound. No significantdifference in the dailyinsulin dosage andnumber of injections werefound between groups.Compared with the controlgroup, frequency of self-blood glucose monitoringincreased significantly inboth experimental groups.No significant effect ofeducation on the numberof sick days was found.

program, andthe lack ofsupportivechanges instandardtherapy andfollow-up of theeducationgiven.

2175 Kaplanet al.,1987

S : 76 volunteer adultswith type 2 diabetes(44 women), mean age= 55.F/U: 3, 6, 12, and 18months.D: RCTST: Community

I: Behavioral-basedgroup intervention.Each participant wasassigned to one of thethree 10-weekprograms: 1) diet, 2)exercise, 3) diet plusexercise.C: 10-week programsof group education.

Direct cost for dietand exercisecombined program isestimated to be$1000 (1986 dollar)per participant(including charges forhistory and physical,lab work, sessions,and medicalconsultations). This isnon-incremental cost.

70/76 completed follow-upstudy. At 18 months, thecombination diet-and-exercise group had achievedthe greatest reductions inglycosylated hemoglobinmeasures. In addition, thisgroup showed significantimprovements on a generalquality of life measure, equalto 0.092 incremental yearsof well-being for eachparticipant compared tocontrol.

N/A. Authorsreportedcost/utility =$10870/wellyear. However,cost is notcalculatedincrementally(if so, the C/Urate would bemorefavorable).

0749 Arsennau et al.,1994

S : 40 patients (mean= 59) attendingdiabetes educationprogramF/U: 2 and 5 monthsD: RCTST : Hospital

I : Individualizedlearning activitypackages (LAP)C: Classroominstruction

Instruction at thehospital costs $31 perhour (1995 dollar),The three LAPs weredeveloped to require3.5 hours ofinstructional time.Thus using LAPscould save individuals

At the 5-month f/u, the LAPgroup scored significantlyhigher on knowledgeassessment and decreasedpercent of ideal body weight.Patients who receivedclassroom instructionexhibited significantlydecreased glycosylated

Not studied. LAPs couldprovide acheapermeans of edu.,but lesseffectivenessin loweringblood glucoselevels than



231

$108.50 ininstructional fees.

hemoglobin levels. classroom edu.

2586 Campbell et al.,1996

S : 238 type 2 DMpatients, 80 years oryounger (mean = 58,51% female) withoutprevious formalinstruction in diabetescare.F/U: 3, 6, and 12monthsD: RCTST: Patients werereferred to a DiabetesEducation Service foreducation programs.Behavioral programwas conducted inpatient home.

I: Comparing relativeeffectiveness of thefollowing programs: 1)minimal instructionprogram, 2) educationprogram of individualvisits, 3) educationprogram incorporatinga group educationcourse, 4) behavioralprogram. (Note: 2) and3) are standard care.)

Not reported, butinvolving 1) two 1-hour sessions, 2) twoinitial sessions, and30 minuets monthlysession for 1 year, 3)at least two individualsessions and a 3-daysmall group educationcourse, as well astwo-hour groupfollow-ups at 3 & 9months, 4) 6 or moreindividual visits from anurse educator

Individual and groupeducation programs hadhigher attrition rates (40%)than the behavioral andminimal programs (10%). Nodifferent outcomes werefound between groups interms of physiologicalmeasures and BMI, exceptfor behavioral programproduced a greaterreduction in diastolic bloodpressure over 12 mos and agreater reduction in thecholesterol risk ratio over 3mos. The behavioralprogram patients reportedhigher satisfaction.

There were no differencesbetween groups overthree time periods inproportion of patientsconsulting anophthapmologist. Thebehavioral programpatients were more likelyto have visited a podiatristafter 6 months. Thegroups did not differ interms of a mean numberof visits they had made toa general practitioner , inhospital admissions, or inthe proportion who hadchanged the intensity oftheir blood pressuretreatment.

Programs thatare moreintensive interms ofpatient timeand resourcesmay not bemore effective,and thus beless cost-effective.

3433 Glasgow et al.,1997

S : 206 diabeticpatients 40 years andolder (mean age = 62,62% female)F/U: 12 monthsD: RCTST: Outpatient clinics

I: Individualized,medical office-basedintervention focusedon dietary self-management, involvedtouch screencomputer-assistedassessment thatprovided feedback onkey barriers to dietaryself-management, goalsetting and problem-solving counseling.Follow-up componentsincluded phone callsand videotapeintervention relevant toeach participant.C: Usual care

From the perspectiveof a health careorganization, theincremental cost forthe delivery of theintervention totaled$14,755, or $137 perparticipant (1995dollars).

The intervention producedsignificantly greaterimprovement than usualcare on multiple measuresof change in dietarybehavior (e.g., covariateadjusted difference of 2.2%of calories from fat; p=0.023) and on serumcholesterol levels (covariateadjusted difference of15mg/dl; p = 0.002) at 12-month follow-up. Therewere also signicicantdifferences favoringintervention on patientsatisfaction (p < 0.02). Nosignificant improvement oneither HbA1c or on BMI.

Not studied. $7-$8 permg/dlreduction incholesterolcompare wellto estimates ofalternativeinterventionincludingcholesterolloweringmedications,which can costfrom $350 to$1400 perpatient year.

1668 Sadur et S : 185 patients of a I: Multidisciplinary Not reported, but may After the intervention, HbA1c Intervention group For patients



232

al.,1999

HMO aged 16-75(mean = 56, 43%female) and had eitherpoor glycemic controlor no HbA1c testperformed during theprevious yearF/U : 6 and 12 monthsafter randomizationD: RCTST: Outpatient clinic

outpatient diabetescare managementdelivered by a diabetesnurse educator, apsychologist, anutritionist, and apharmacist in clustervisit settings of 10-18patients/month for 6months.C: Usual care

not be more costlythan usual care since3 providers saw 12-18 patients for a 2-hour session monthly(somewhat highernumber of patientsthan these sameproviders would seein one-on-onesessions during thesame 2 hour), andmodestly reducedphysician visits.

levels declined significantlyin the intervention subjectscompared to controlsubjects. Several self-carepractices and severalmeasures of self-efficacyimproved significantly in theintervention group.Satisfaction with theprogram was high.Limitation: Failure to obtainfollow-up HbA1c levels andquestionnaires on 16% and25% of subjectsrespectively.

patients had somewhathigher ambulatory careutilization and moreintensive pharmaceuticalmanagement than controlsubjects during the 6-month intervention. Thisexcess utilization wasoffset by fewer hospitaladmissions after theintervention. Both hospitaland outpatient utilizationwere significantly lower forintervention subjects afterthe end of the program.

who had poordiabeticmanagement,providing thisintensivemanagementprogram maybe cost neutralin the shortterm (< 2years).

0828 Litzelman et al.,1993

S : 395 patients withtype 2 DM whounderwent the initialpatient riskassessment (352completed the study)(mean age = 60, 81%female, most subjectsare poorly educatedand indigent blackwomen)F/U : Completion ofintervention (12 monthfrom initialassessment)D: RCTST: Academicoutpatient clinic

I: Multifaceted,including 1) patienteducation andbehavioral contractabout foot-care, andalso reinforcementreminders, 2) healthcare system support ofidentifiers on patientfolders to promptproviders, 3) givenproviders practiceguidelines andinformational flowsheets on foot-relatedrisk factors foramputation.C: Usual care

The study materials,including folders, footdecals, postage,printing, andeducational materials,cost less than $5000.The major expense ofthe study was thesalary support for thenurse-clinicians whodid the assessmentsand for the researchassistant whoprocessed the charts.

Patients receiving theintervention were less likelythan control patients to haveserious foot lesions (oddsratio 0.41, p = 0.05) andother dermatologicalabnormalities. Also theywere more likely to reportappropriate self-foot-carebehaviors, to have footexaminations during officevisits (68% vs. 28%, p <0.001), and to receive foot-care education from healthcare providers (42% vs.18%, p < 0.001). Physiciansassigned to interventionpatients were more likelythan physicians assigned tocontrol patients to examinepatients’ feet.

At the end of theintervention, fouramputations had beendone in the control groupcompared with one in theintervention group.(Incidence rate is toosmall to test statisticalsignificance). Physiciansassigned to interventionpatients were more likelythan physicians assignedto control patients to referpatients to the podiatryclinic, but no difference inthe pattern of patientreferral to orthopedics andvascular surgery clinics.

Indicative cost-effective.Insufficientinformationabout costsaving.

Osteoarthritis0830 Lorig et

al.,1986

S : 100 subjects witharthritis. 85 completedstudy. Mean age = 64.73% female. 73% had

I1 = An Arthritis Self-Management course(ASM) group taught bya male rheumatologist

The 12-hour coursetaught by 2 lay-leaders would costfrom $0.00

Professional-taught groupsdemonstrated greaterknowledge gain while lay-taught groups had greater

No significant difference innumber of visits tophysician at 4 monthsfollow-up between groups

Lay-taughtASM coursecould be aseffective as



233

OA.F/U: 4 monthsD: RCTST: Community sites

and a female physicaltherapist.I2 = An ASM coursegroup taught by 2female lay-leaders.C: No intervention.

(volunteer) to $200(1985 dollars). By onehealth professional,the course would costfrom $240 ($20/h) to$600 ($50/h). Thecosts of training andsupport for lay-leaders were notaccounted.

changes in relaxation thanthe other two groups. Thesubjects who received ASMcourse were more likely toexercise, and a tendencytoward less disability thancontrol subjects.

or change from baseline. professional-taught yetcheaper.However, bothfailed todemonstratereduction innumber ofphysicianvisits.

0835 Lorig etal.,1985

S : 190 subjects witharthritis. Mean age =67. 83% female. 77%had OA.F/U: 4 months RCTand 20 monthslongitudinal study.D: RCT + longitudinalstudyST: Community sites

I: An Arthritis Self-Management course(ASM) given in 6sessions by laypersons, based on astandardizededucational protocolemphasizing groupdiscussion, practice,the use of contractsand diaries to improvecompliance, andweekly feedback. Nosubsequentreinforcement. (129subjects)C: Delayedintervention for 4months. (61 subjects)

$15 to $20 perparticipant. (1983dollars).

At 4 months, experimentalsubjects significantlyexceeded control subjects inknowledge, recommendedbehaviors, and in lessenedpain. These changesremained significant at 20months.

At 4 months, there was atendency of decline invisits to physicians by theintervention group, but didnot reach statisticalsignificance at .05 level.The 20 monthslongitudinal study showedthe number of physicianvisits reduced frombaseline to 4-month f/u,and from 4 months to 8-months, and remainedabout the same from 8months to 20 months.These changes did notreach statisticalsigniciance.

Indicative cost-effective.Insufficientinformationabout costsaving.

Mazzuca et al.,1999

S : 211 patients withknee OA from thegeneral medicine clnicof a municipal hospital(Of which 25 lost tof/u). Mean age = 63.85% female.F/U: 1 yearD: CT (NonrandomizedAttention-controlledclinical trial)

I : Self-care education:Individualizedinstruction and follow-up emphasizingnonpharmacologicmanagement of jointpainC: A standard publiceducation presentationand attention-controlling follow-up.

The cost ofdeliverying the self-care educationintervention to 105subjects was $6,163(in 1996 dollars), orequivalently, $58.70per patient.

See health care costs orutilizations.

The 94 subjects remainingin intervention groupmade 528 primary carevisits during the follow-upyear, while the 92controlled patients made616 visits. The averagesubject in interventiongroup generated $262 inclinic costs, comparedwith $322 for the average

For more than50% ofpatientsreceiving theintervention,the reducedoutpatientvisits and costsoffset theinterventioncosts. 80% of



234

ST: Outpatient clinic subject in control group.The frequencies and costsassociated with chargesfor drugs, radiography,and laboratory tests weresimilar between groups.

theinterventioncosts wasoffset withinone year dueto reducedoutpatientvisits.

Groessl&Cronan,2000

S : 363 members of aHMO, 60 years of ageand older with OA.Mean age = 70.F/U: 3 yearsD: RCTST: Community

I1: Social supportI2: EducationI3: A combination ofsocial support andeducationC: Usual care

$9450 for socialsupport group,$18675 for educationgroup, and $14175for combinationgroup, totaling$42300 (all in 1992dollars).

Feelings of helplessnessdecreased in theintervention groups but notin the control group. Allgroups showed increases inself-efficacy and overallhealth status.

Health care costsincreased less in theintervention groups than inthe control group. Basedon the HMO data, healthcare cost savings were$1,156/participant for yearone and two, and$1,279/participant for yearthree (1992 dollars).

Cost effectiveand costsaving. Theone-year cost-benefit ratiowas $7.29:1.The three-yearcost-benefitratio was$22.05:1.

Hypertension2457 Hoelsch

er et al.,1986

S: 50 (24 female) adultaverage 51.1 years ofage with essentialhypertension recruitedvia mediaannouncements.Secondaryhypertension or withmean baseline bloodpressures greater than180 mm Hg systolic or120 mm Hg diastolicwere excluded.F/U: 6 weeksD: RCTST: Patient home

I: 1) individualizedrelaxation (IR), 2)group relaxation (GR),3) group relaxationplus contingencycontracting for homepractice (GRCC)C: Waiting list control

Measured bytherapist time

Measured by percentreductions in systolic anddiastolic blood pressure, andby eliciting home relaxationpractice

Not measured. GR wassignificantlymore costeffective thanIR for systolic,whereas bothGR and GRCCwere morecost effectivethan IR fordiastolic bloodpressure. Foramount ofrelaxationpractice, GR >GRCC > IR.

Post Myocardial Infarction Care2669 DeBusk

et al.,1985

S: 198 men 70 yearsor younger, had hadclinicallyuncomplicated AMI,

I1A: Medically directedat-home rehabilitationtraining for 23 weeksI1B: Medically directed

Three months of at-home rehabilitationwas estimated to beapproximately $328

Compared to the grouprehabilitation, medicallydirected at-homerehabilitation had about

Not studied. Medicallydirected at-homerehabilitation



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mean age 52 ± 9years.F/U: 26 weeksD: RCTST: Patient home orcommunity gymnasium

at-home training for 8weeksI2A: Supervised grouptraining in agymnasium for 23weeksI2A: Supervised grouptraining in agymnasium for 8weeksI3: Exercise testingwithout subsequentexercise trainingC: Neither testing nortraining

per patient (1982 or1983 dollar). Thegroup rehabilitationprogram wasapproximately $720.

equally high adherence toindividually prescribedexercise, increase infunctional capacity, and lownonfatal reinfarction anddropout rates. Compared tothe no-training and controlgroups, the training groupswere significantly greater infunctional capacity, but notdifferent in cardiac events.

has thepotential todecrease thecost ofrehabilitatinglow-risksurvivors ofAMI.

0827 Lewin etal.,1992

S: 176 male andfemale patients with anAMI and age less than80 years (mean age =55.8 ± 10.6 years)F/U: 1 yearD: RCTST: Patient home

I: A comprehensiveself-help rehabilitationprogramme based ona heart manualSpouses were givenmaterials to supportand encouragecompliance bypatients. Includedfollow-up andfeedback.C: Standard care plusa placebo package ofinformation andinformal counseling.

The authorsestimated the cost oftreatment per patientto be £30 - £50 (1990dollar).

Psychological adjustmentwas better in therehabilitation group at 1year. The improvement wasgreatest among patientswho were clinically anxiousor depressed at dischargefrom hospital.

The two groupssignificantly differed in thenumber of GPconsultations at sixmonths and after thesecond six months; thecontrol group made amean of 1.8 more visitsthan did the rehabilitationgroup in the first 6months, and a mean of0.9 more visits in thesubsequent 6 months. Inaddition, significantly morecontrol patients thanrehabilitation grouppatients were admitted tohospital in the first 6months (18 vs. 6) but notat 12 months (18 vs. 9).Significantly fewerrehabilitation grouppatients were readmittedto hospital in the first 6months (8% vs. 24%).

Based onphysician self-report data foruse of healthservices.Indicative cost-saving.

Non-disease-specific Programs



236

1175 Leveilleet al.,1998

S: 201 chronically illseniors aged 70 andolder (mean age =77.1 years) with heartdisease, high bloodpressure, arthritis,cancer, stroke, ordiabetes. More % offemale in interventionthan in control (63.4%vs. 48.0%)F/U: 1 yearD: RCTST: A large seniorcenter, in collaborationwith primary careproviders of MCOs.

I: A geriatric nursepractitioner (GNP) ledmulti-componentprogram including riskfactor and healthassessment, feedbackto PCPs, follow-upvisits and phonecontacts, physicalactivity for disabilityprevention, andindividual counselingabout disease self-management as wellas group classes.C: Access to all seniorcenter activities, but noGNP.

The authorsestimated theprogram cost(primarily the salariesfor the GNP and thesocial worker) to beapproximately $300(1997 dollar) annuallyper participant.

The intervention groupshowed less decline infunction, as measured bydisability days and lowerscores on the HealthAssessment Questionnaire.However, the measures bySF-36 and a battery ofphysical performance testsdid not show difference byintervention. Theintervention led tosignificantly higher levels ofphysical activity and seniorcenter participation.

The number ofhospitalized participantsincreased by 69% (from13 to 22) among thecontrols and decreased by38% (from 21 to 13) inthe intervention group (p =.083). The total number ofinpatient hospital daysduring the study yeardecreased by 72% in theintervention group butincreased by 21% in thecontrol group(p = .049). The 83 lesshospital days in theintervention group yieldeda savings ofapproximately $1200 perparticipant. Outpatientvisits did not change in theintervention group butslightly increased in thecontrol group. There weretwo less ER visits in theintervention group but 8less ER visits in thecontrol group.

Indicative costsaving, due toless hospitaluse.

1510 Coleman etal./1999

S: 169 patients aged65 and older (mean =77) with the highestrisk for beinghospitalized orexperiencing functionaldeclineF/U: 2 yearsD: RCTST: Nine primary carephysician offices in alarge staff-model HMO

I: Chronic Care Clinicsattempted toreorganize the deliveryof primary careservices to better meetthe needs of olderpersons with chronicillness, includingdisease managementplanning, medicationreview, patient self-management/supportgroup)

Not available. After 24 months, nosignificant improvements infrequency of incontinence,proportion with falls,depression scores, physicalfunction scores, orprescriptions of high riskmedications weredemonstrated. A higherproportion of interventionpatients rated the overallquality of their medical careas excellent compared with

At baseline, interventionpatients were more likelyto be hospitalized. Duringthe 24-month follow-up,costs of medical careincluding frequency ofhospitalization, hospitaldays, emergency andambulatory visit, and totalcosts of care were notsignificantly differentbetween intervention andcontrol groups.

Insufficientinformation(implied notcost saving).



237

C: Usual care control patients (40% vs.25%, p = 0.1)

0608 Lorig etal.,1999

S: 952 patients 40years and older (mean= 65) with heartdisease, lung disease,stroke, or arthritis.F/U: 6 monthsD: RCTST: Community-basedsites (churches, seniorand communitycenters, publiclibraries, & health carefacilities)

I: Subjects receivedthe Chronic DiseaseSelf-ManagementProgram (CDSMP), acommunity-basedpatient self-managementeducation course. Thecontent andmethodology of theCDSMP were basedon needsassessments. Theprocess of teachingthe course is based onSelf-Efficacy Theory.The course was taughtby a pair of trained,volunteer lay leaders.C: Waiting list control

The authorsestimated theprogram cost to beapproximately $70(1998 dollar) perinterventionparticipant. Thisincludes $26 fortraining leaders, $14for volunteer leaderstipend, $15 forcourse materials, and$15 administrativecosts. This analysisdoes not take intoaccount the cost ofspace or indirectcosts.

At 6 months, treatmentsubjects demonstratedimprovements in weeklyminutes of exercise,frequency of cognitivesymptom management,communication withphysicians, self-reportedhealth, health distress,fatigue, disability, andsocial/role activitieslimitations, compared withcontrol subjects. Programeffects were similar acrossall four diagnosticsubgroups.

Based on patient self-report, the treatmentgroup reduced theirphysician visits slightlymore, but not significantly,than did the control group.However, the decrease inthe number ofhospitalizations and in thelength of hospital stayswere significant at p <.05.Assuming a cost of $1000per day of hospitalization,the 6-month health carecosts for each controlparticipant in this studywere $820 greater than foreach treatment subjects.

Cost-effectiveand indicativecost-saving(approximatelya saving of$750 perparticipant,according toauthorestimatesbased onpatient self-reportedutilizationdata).


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